Review article: 2014 UK consensus guidelines – hepatitis C management and direct‐acting anti‐viral therapy

“…Recently emerged direct anti-viral agents do not seem to directly contribute to HRQL impairment, but, as long as they are used in combination with interferon, will not eliminate any of interferon-associated side effects and the HRQL impairment either. [25][26][27][28] On the other hand, the newly emerging interferon-free regimens [29][30][31][32][33][34] are expected to result in less if any adverse events and, therefore, better health utility scores for patients undergoing anti-HCV treatment. However, the health utility scores that could be used in cost-effectiveness analyses of interferon-free anti-HCV therapies are yet to be reported.…”

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confidence: 99%

Patients' preferences and health utility assessment with SF‐6D and EQ‐5D in patients with chronic hepatitis C treated with sofosbuvir regimens

Stepanova

Nader

Cure

et al. 2014

Aliment Pharmacol Ther

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Summary Background Health utilities measure patients' preferences for a health state. Aim To assess health utilities for sofosbuvir‐containing therapy for chronic hepatitis C. Methods The SF‐6D utility scores were derived from the SF‐36 instrument administered at baseline, during and post‐treatment to participants of the previously reported clinical trials of sofosbuvir. EQ‐5D utility scores were also approximated from the SF‐36 using a regression model. Results Nine hundred and ninety‐four patients were enrolled. Baseline SF‐6D and EQ‐5D scores were 0.66 ± 0.13 and 0.71 ± 0.22, respectively (the POSITRON trial), 0.71 ± 0.16 and 0.76 ± 0.23 (FISSION), 0.70 ± 0.14 and 0.75 ± 0.22 (FUSION), 0.72 ± 0.15 and 0.79 ± 0.22 (NEUTRINO). In all studies, SF‐6D and EQ‐5D scores were highly correlated with each other. (r = 0.83–0.87, P < 0.0001). After 12 weeks, patients receiving sofosbuvir + ribavirin (POSITRON) had similar utility scores to placebo (P > 0.05). Patients receiving 12 and 16 weeks of sofosbuvir + ribavirin (FUSION) had similar utility scores (P > 0.05). In FISSION, patients receiving sofosbuvir + ribavirin had significantly better utilities compared to patients receiving interferon + ribavirin (P < 0.001). Patients receiving sofosbuvir + ribavirin + interferon (NEUTRINO) had a decrease in utilities during treatment (SF‐6D: from 0.72 to 0.62, EQ‐5D: 0.79 to 0.65; P < 0.0001) similar to that observed in patients receiving pegylated interferon + ribavirin for 24 weeks in FISSION (0.72 to 0.62 and 0.77 to 0.65, respectively, P < 0.0001). After 12 weeks post‐treatment, patients with SVR (FUSION) had improvement in SF‐6D (+0.026 from baseline, P = 0.013) and EQ‐5D (+0.043, P = 0.013). In multivariate analyses, baseline depression, anxiety, fatigue, insomnia and treatment‐related anaemia were the most consistent predictors of utilities. Conclusions Patients' health utilities are minimally impacted by sofosbuvir + ribavirin treatment, as compared to interferon‐based, therapy regardless of treatment duration. Clinical trials' numbers: NCT01542788 (POSITRON), NCT01497366 (FISSION), NCT01604850 (FUSION), NCT01641640 (NEUTRINO).

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“…First summary reports implement suggestions for IFNfree treatment regimens for LT patients [52,53] . However, there remain several challenges and uncertainties for the use of IFN-free regimens to treat patients with very aggressive forms of hepatitis C (such as FCH), which occurs very early after transplantation.…”

Section: Resultsmentioning

confidence: 99%

Hepatitis C virus reinfection after liver transplant: New chances and new challenges in the era of direct-acting antiviral agents

Herzer

Gerken

2015

WJH

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The first interferon-free regimens have been approved for the treatment of patients with chronic hepatitis C virus (HCV). In the liver transplant (LT) setting, these regimens are expected to have an important effect, because graft loss due to HCV recurrence is a serious problem after LT. The response to the hitherto conventional treatment with pegylated interferon and ribavirin is poor. The significantly better response rates achieved with boceprevir-based and telaprevirbased triple therapy have led to better graft and patient survival rates, but severe drug interactions with immunosuppressants limit the feasibility of this therapy for LT patients. With the approval of sofosbuvir in January 2014, of simeprevir in May 2014, and of daclatasvir in August 2014, three antiviral agents are now available and promise to be applicable without relevant adverse effects or negative interactions with immunosuppressants. Thus, 2014 marks the beginning of a new era of treatment options for HCV recurrence after LT. Although safety and efficacy studies of several interferon-free regimens for patients with HCV recurrence after LT have achieved good preliminary results, reports of clinical experiences with LT patients are scarce. The lack of randomized studies, the small number of enrolled and carefully selected patients, and the heterogeneity of these studies make the results questionable. Real-life experiences are eagerly awaited so that clinicians can estimate the usefulness and the pitfalls of these new regimens. Additionally, the high costs of these agents may limit their accessibility for many patients. The aim of this review is to summarize the current experience with and the expectations of the new direct-acting antiviral agents for LT patients. Core tip: In the liver transplant (LT) setting, graft loss due to hepatitis C virus (HCV) recurrence is a serious problem after LT. The former conventional treatment with pegylated interferon and ribavirin is unsatisfying, due to poor response rates and tolerability. With the first interferon-free regimens that are currently being approved for the treatment of patients with chronic HCV, 2014 marks the beginning of a new era MINIREVIEWSSubmit a

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Review article: 2014 UK consensus guidelines – hepatitis C management and direct‐acting anti‐viral therapy

Cited by 34 publications

References 29 publications

SASLT guidelines: Update in treatment of Hepatitis C virus infection

SASLT guidelines: Update in treatment of Hepatitis C virus infection

Patients' preferences and health utility assessment with SF‐6D and EQ‐5D in patients with chronic hepatitis C treated with sofosbuvir regimens

Hepatitis C virus reinfection after liver transplant: New chances and new challenges in the era of direct-acting antiviral agents

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